Home NDC 50383-913 Famotidine
Product NDC 50383-913
11-digit product format 503830913
Labeler code 50383
Product ID 50383-913_f448e568-540e-4027-be47-e7a5aa1051d3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Famotidine
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Akorn
Application ANDA201995
Marketing category ANDA
Marketing start 2016-03-16
Substance FAMOTIDINE
Active strength 40 mg/5mL
Pharmacologic classes Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A201995-001 FAMOTIDINE FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201995-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201995-001 FAMOTIDINE 40MG/5ML FOR SUSPENSION / ORAL AB 2014-05-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Famotidine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FAMOTIDINE 40 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5QZO15J2Z8 Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50383-913-40 Famotidine 1 in 1 CARTON POWDER, FOR SOLUTION 1 6 50383-913-40 Famotidine 50 mL in 1 BOTTLE, GLASS POWDER, FOR SOLUTION 50 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50383-913 FAMOTIDINE POWDER, FOR SOLUTION [AKORN] 6 Current NDC, Legacy NDC, 2 package rows 20220323_354a5a02-45cb-4ab0-88ee-6635d5a43b01.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50383-913-40 50383091340 1 BOTTLE, GLASS in 1 CARTON (50383-913-40) / 50 mL in 1 BOTTLE, GLASS 2016-03-16 0000-00-00 No No Current